Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT03599492
Eligibility Criteria:
Inclusion Criteria:
* Patients with either radiographic or biopsy proven decompensated cirrhosis (as determined by ascites, variceal hemorrhage, encephalopathy or jaundice).
* Patients undergoing an elective TIPS for any standard of care established indication (examples: worsening ascites, recurrent variceal bleeding).
Exclusion Criteria:
* Pregnant women.
* Patients unwilling or unable to provide informed consent.
* Patients undergoing an emergent TIPS for acute or subacute variceal hemorrhage.
* Patients with diabetes, significant cardiovascular, renal or other chronic disease which has been known to affect intestinal motility.
* Previously diagnosed gastroparesis or other GI dysmotility disorder.
* Patients currently taking narcotics, antibiotics excluding rifaximin, prokinetic medications or lactulose.
* Patients with a history of gastric bezoar.
* Patients with a history of multiple intestinal surgeries or GI surgery within the past 3 months.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of gastrointestinal strictures, fistulas, or physiological or mechanical obstruction.
* Patients with a history of diverticulitis.
* Patients with swallowing disorders and increased risk of aspiration (such as prior history of aspiration).
* Patient with Celiac disease.
* Patients with implanted or portable electro-mechanical medical devices.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03599492
Study Brief:
Protocol Section:
NCT03599492